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A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
comfilcon A
fanfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. They are aged 18-50 and have capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They are an existing wearer of reusable, single vision, spherical soft contact lenses.
  5. They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
  6. They have a spectacle cylindrical correction of -1.00D or less in each eye.
  7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breastfeeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Sites / Locations

  • The University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

comfilcon A with Hy-Care Multi-purpose solution

comfilcon A with All in One Light Multi-purpose solution

comfilcon A with Refine One Step Hydrogen Peroxide Solution

fanfilcon A with Hy-Care Multi-purpose solution

fanfilcon A with All in One Light multi-purpose solution

fanfilcon A with Refine One Step Hydrogen Peroxide Solution

Arm Description

Subjects were randomized to wear each lens and solution combination for a month.

Subjects were randomized to wear each lens and solution combination for a month.

Subjects were randomized to wear each lens and solution combination for a month.

Subjects were randomized to wear each lens and solution combination for a month.

Subjects were randomized to wear each lens and solution combination for a month.

Subjects were randomized to wear each lens and solution combination for a month.

Outcomes

Primary Outcome Measures

Overall Comfort
Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort on Insertion
Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort Before Removal
Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

Secondary Outcome Measures

Vision
Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Variable Vision
Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision).
Vision at Night
Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Dryness
Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever).
Ocular Redness
Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness).
Burning/Stinging
Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging).
Ease of Lens Insertion
Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion).
Ease of Lens Removal
Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal).

Full Information

First Posted
December 10, 2019
Last Updated
May 18, 2021
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04195581
Brief Title
A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Official Title
A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.
Detailed Description
This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A with Hy-Care Multi-purpose solution
Arm Type
Experimental
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Arm Title
comfilcon A with All in One Light Multi-purpose solution
Arm Type
Experimental
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Arm Title
comfilcon A with Refine One Step Hydrogen Peroxide Solution
Arm Type
Experimental
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Arm Title
fanfilcon A with Hy-Care Multi-purpose solution
Arm Type
Active Comparator
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Arm Title
fanfilcon A with All in One Light multi-purpose solution
Arm Type
Active Comparator
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Arm Title
fanfilcon A with Refine One Step Hydrogen Peroxide Solution
Arm Type
Active Comparator
Arm Description
Subjects were randomized to wear each lens and solution combination for a month.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
Subjects were randomized to wear each lens and solution combination for a month.
Intervention Type
Device
Intervention Name(s)
fanfilcon A
Intervention Description
Subjects were randomized to wear each lens and solution combination for a month.
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Time Frame
One Month
Title
Comfort on Insertion
Description
Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Time Frame
One Month
Title
Comfort Before Removal
Description
Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Time Frame
One Month
Secondary Outcome Measure Information:
Title
Vision
Description
Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Time Frame
One Month
Title
Variable Vision
Description
Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision).
Time Frame
One Month
Title
Vision at Night
Description
Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)
Time Frame
One Month
Title
Dryness
Description
Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever).
Time Frame
One Month
Title
Ocular Redness
Description
Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness).
Time Frame
One Month
Title
Burning/Stinging
Description
Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging).
Time Frame
One Month
Title
Ease of Lens Insertion
Description
Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion).
Time Frame
One Month
Title
Ease of Lens Removal
Description
Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal).
Time Frame
One Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: They are aged 18-50 and have capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They are an existing wearer of reusable, single vision, spherical soft contact lenses. They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive) They have a spectacle cylindrical correction of -1.00D or less in each eye. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). They agree not to participate in other clinical research for the duration of the study. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They have had cataract surgery. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or breastfeeding. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, MCOptom FAAO FBCLA
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manchester
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

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